FDA EIR - Fresenius Kabi USA LLC - September 01, 2015

Fresenius Kabi USA LLC, located in Melrose Park, IL, underwent an FDA surveillance inspection from August 17 to September 1, 2015. This comprehensive inspection, conducted under Compliance Programs 7356.002 and 7356.002A for drug manufacturing and sterile drug processes, covered all six quality systems at the facility, which produces sterile human drug products.The inspection identified one primary observation documented on an FDA-483: the company's packaging and labeling operations, specifically those involving cut labels and visual inspection on non-dedicated lines, lacked independent verification by a second person. In response, company management immediately retrained staff on existing written procedures for labeling verification and committed to a formal written response within 15 days.Additionally, during the close-out meeting, the FDA discussed the marketing of unapproved drug products. Fresenius Kabi provided a list of these products and confirmed ongoing communication with the FDA's Center for Drug Evaluation and Research (CDER) regarding their market necessity and filing status.The report also noted that corrections from a prior inspection (September-December 2013), which cited issues with quality control unit procedures, equipment design for cleaning, and procedures to prevent microbiological contamination, had been verified as implemented. Since the last inspection, the firm also conducted five product recalls in cooperation with the Chicago District Office. The facility's drug manufacturing registration was current.